FDA 483 - Kalitec Direct, LLC - March 04, 2020

An FDA inspection of Kalitec Direct, LLC, a medical device establishment in Oviedo, FL, identified two observations. The firm's procedures for purchasing controls were found inadequate, specifically concerning critical suppliers' process validation and personnel training. Additionally, the company's complaint handling procedures were deficient, as investigations did not consistently identify the most probable cause, particularly when user error was a potential factor.